JP2004522506A - Method and apparatus for improving blood flow by a series of electrically induced muscle contractions - Google Patents

Abstract

A therapeutic method and apparatus for promoting a local increase in blood flow through a blood vessel in a region of the body. The method comprises: (a) (i) at least a first electrode (80a, 80b) operatively contacting a first portion of body tissue; (ii) operatively contacting a second portion of body tissue. At least a second electrode (82a, 82b) and (iii) a signal generator (87, 85) operatively connected to the first and second electrodes for providing a plurality of electrical stimuli to the electrodes. Providing a system, (b) inducing a directional repetitive contractile movement in the muscle tissue associated with the blood vessel by applying the electrical stimulation to the muscle tissue by subjecting the muscle tissue to at least one voltage difference, and providing a blood flow Generating a local increase.

Description

【Technical field】
[0001]
The present invention relates to a method of increasing blood flow, and in particular to energizing a muscle associated with a blood vessel, thereby inducing a local increase in blood flow through the blood vessel by inducing a repetitive contractile movement of the muscle tissue. About the method. This repetitive contractile movement of muscle tissue produces vascular peristalsis that increases blood flow. Alternatively, repetitive contractile movements of muscle tissue can be induced so that blood flow to any region is reduced relative to blood flow.
[0002]
The methods presented herein address a variety of problems associated with impaired blood circulation, including treatments to improve retention drainage, reduce muscle and tissue pain, and control erectile function. Suitable for various medical uses. Blood flow stimulation is particularly important in the treatment of limb and / or organ ulcers suffering from poor blood circulation, such as increasing blood flow to the toes of diabetic patients or increasing the rate at which edema is drained from the body cavity. is there. Restricted blood flow is also suitable for a wide variety of medical applications, including various surgical procedures.
[Background Art]
[0003]
Current treatments to improve blood circulation and reduce neural and muscle pain include manual, electrical, and mechanical methods. Manual treatment with physical therapy requires massage by a qualified person. This technique cannot be prescribed in an appropriately standardized form, as it depends on the experience and skills of the individual massage therapist. Also, the improvement of blood circulation is very limited.
[0004]
Electrical muscle stimulation (EMS) is widely used in many applications. The Food and Drug Administration (Section 355.200 Electric Muscle Stimulator, CPG 7124.26) has stated that in the health care community, EMS devices will be able to improve muscle retraining, reduce muscle spasm, extend exercise range, treat unused atrophy, Claims to be considered effective for immediate postoperative stimulation of calf muscle to increase local blood circulation and prevent venous thrombosis. However, it must be emphasized that the stimulus provided by the EMS is very similar to the stimulus provided by the massage treatment. Increases in blood circulation are very weak and often cannot be detected using conventional flow measurement devices, such as Doppler-based devices. EMS is a random stimulus of a localized tissue area. Thus, as with massage treatments, hydrothermal treatments, etc., EMS methods cannot provide a significant increase in local blood flow. Furthermore, because the stimulation is random, the EMS method cannot basically provide a local reduction in blood flow.
[0005]
Sequential pneumatic devices for reducing edema are also known. The device is comprised of a plurality of overlapping compartments contained within a sleeve assembly. These compartments are continuously inflated from the distal end located proximal to the edema to the proximal end to push the edema proximally. The pump fills the individual compartments with air, but the cycle begins by filling the distal compartments, filling the remaining compartments until all compartments are filled. After the contraction period, the cycle is repeated.
[0006]
In such electromechanical equipment, an electric motor, a reciprocating mechanism, and the like generate unpleasant noise and vibration. Furthermore, these treatments have the disadvantage that various device components have to be brought into contact with the skin. These elements often cause discomfort to the patient and require replacement and cleaning after each use to ensure hygiene.
[0007]
Accordingly, there is a need for a method of promoting, controlling, and / or reducing local fluid circulation through blood vessels as needed. It would be very advantageous to have such a method, and it would be even more beneficial if the method was simple, easy to use, non-invasive, repeatable, and adjustable to the individual needs of the patient. is there.
DISCLOSURE OF THE INVENTION
[0008]
According to the present invention, there is provided a treatment method for promoting a local increase in blood flow through a blood vessel in a region of the body, comprising the following steps. (A) (i) at least a first electrode operatively in contact with a first portion of body tissue, (ii) at least a second electrode in operative contact with a second portion of body tissue, and (iii) C.) Providing a system including a signal generator operatively connected to the first and second electrodes for providing a plurality of electrical stimuli to the electrodes; (B) applying electrical stimulation to expose the muscle tissue to at least one voltage difference to induce a directional repetitive contraction movement in the muscle tissue associated with the blood vessel, resulting in a local increase in blood flow through the blood vessel; Generating step.
[0009]
Further, according to another aspect of the present invention, there is provided a treatment method for promoting a local change in blood flow through a blood vessel in a region of a body, comprising the following steps. (A) (i) at least a first electrode operatively in contact with a first portion of body tissue, (ii) at least a second electrode in operative contact with a second portion of body tissue, and (iii) C.) Providing a system including a signal generator operatively connected to the first and second electrodes for providing a plurality of electrical stimuli to the electrodes; (B) arranging at least a first electrode at one end of the region and arranging at least a second electrode at a second end of the region; And (c) applying electrical stimulation to set a voltage difference between the electrodes. In this case, the voltage difference is composed of two waveforms propagating in opposite directions between the electrodes to cause a local change in blood flow through the blood vessel.
[0010]
Further, according to another aspect of the present invention, there is provided a treatment method for promoting a local decrease in blood flow through a blood vessel in a region of a body, comprising the following steps. (A) (i) at least a first electrode operatively in contact with a first portion of body tissue, (ii) at least a second electrode in operative contact with a second portion of body tissue, and (iii) C.) Providing a system including a signal generator operatively connected to the first and second electrodes for providing a plurality of electrical stimuli to the electrodes; And (b) applying electrical stimulation to expose the muscle tissue to at least one voltage difference to induce repetitive contraction movements in the muscle tissue associated with the blood vessel, resulting in a local decrease in blood flow through the blood vessel. Generating step.
[0011]
Further, in accordance with another aspect of the present invention, there is provided an apparatus for promoting local changes in blood flow through a blood vessel. The device comprises: (a) at least a first electrode operatively contacting a first portion of body tissue; (b) at least a second electrode operatively contacting a second portion of body tissue; A) a signal generator operatively connected to the first electrode and the second electrode for providing a plurality of electrical stimuli to the electrodes; and (d) control means for controlling the signals generated by the signal generator. In this case, the control means and the signal generator are designed and configured so that a voltage difference composed of a waveform propagating in a direction facing between the electrodes is set between the electrodes, and the electrodes are moved. This voltage difference facilitates local changes in blood flow through the blood vessels.
[0012]
According to features in the preferred embodiment, the electrical stimulus acts on muscle tissue to generate a periodic repetitive wavy motion that imposes a periodic peristaltic repetitive motion on the blood vessels.
[0013]
Further, according to features in the preferred embodiments described below, the first electrode is a first plurality of electrodes, the second electrode is a second plurality of electrodes, and a local increase in blood flow. Providing an interval between the first plurality of electrodes and the second plurality of electrodes along the entire length of the region, and a continuous between the first plurality of electrodes and the second plurality of electrodes. And by setting repetitive voltage differences.
[0014]
Further, according to features in the preferred embodiments described below, the method further includes the step of: (c) disposing a first electrode at one end of the region and disposing a second electrode at a second end of the region. In this case, the voltage difference set between the electrodes is composed of two waveforms propagating in opposite directions so as to obtain a signal having a predetermined direction, frequency and intensity to induce repetitive contraction movement of muscle tissue.
[0015]
Further, according to features in the preferred embodiments described below, the first electrode is a single first electrode and the second electrode is a single second electrode.
[0016]
Further, according to features in the preferred embodiments described below, the method further includes (c) optimizing a local increase in blood flow.
[0017]
Further, according to features in the preferred embodiments described below, the optimization is based on sensor-controlled adjustments.
[0018]
Further, according to features in the preferred embodiments described below, the optimization is based on blood flow measured by the instrument.
[0019]
Further, according to features in the preferred embodiments described below, the method further includes: (c) obtaining a periodic measurement of blood flow through the blood vessel; and (d) determining a blood flow based on the measurement. Optimizing the local increase or decrease of.
[0020]
Further, according to features in the preferred embodiments described below, the method further includes the step of (c) adjusting a parameter of the wavy signal set across the first electrode and the second electrode.
[0021]
Further, according to features in the preferred embodiments described below, the parameters of the wavy signal include a frequency of the wavy signal.
[0022]
Further, according to features in the preferred embodiments described below, the parameters of the wavy signal include a shape of the wavy signal.
[0023]
Further, according to features in the preferred embodiments described below, the parameters of the wavy signal include a voltage of the wavy signal.
[0024]
Further, according to features in the preferred embodiments described below, the method further includes the step of (c) adjusting the parameters of the repetitive contraction movement to achieve a predetermined target characteristic for blood flow.
[0025]
Further, according to features in the preferred embodiments described below, a pressure sensor is used to measure or indicate blood flow.
[0026]
Further, according to features in the preferred embodiments described below, the method further comprises: (c) applying the plurality of electrical stimuli to a blood pulse corresponding to a heart beat to obtain a local increase in blood flow. Including the step of synchronizing.
[0027]
Further, in accordance with features in the preferred embodiments described below, this synchronization is achieved by monitoring blood pressure in the body.
[0028]
Further, according to features in the preferred embodiments described below, the signal comprises a positive voltage difference phase and a negative voltage difference phase, and the positive and negative phases have a temporal overlap.
[0029]
Further, according to features in the preferred embodiments described below, the temporal overlap is between 1 microsecond and 500 microseconds.
[0030]
Further, according to features in the preferred embodiments described below, the time overlap is between 10 microseconds and 100 microseconds.
[0031]
Further, according to features in the described preferred embodiments, the signal comprises a plurality of positive voltage difference peaks and a plurality of negative voltage difference peaks, each of the peaks having a duration of 30 to 500 microseconds. .
[0032]
Further, according to features in the preferred embodiments described below, each of the peaks has a duration of 50 to 300 microseconds.
[0033]
Further, according to features in the preferred embodiments described below, each of the positive peaks has a duration of 150 to 300 microseconds.
[0034]
Further, according to features in the preferred embodiments described below, the signal comprises a plurality of pulses, each pulse including a positive voltage difference phase and a negative voltage difference phase. In this case, the plurality of pulses have a frequency in the range of 0.5 to 150 pulses per second (PPS).
[0035]
Further, according to features in the preferred embodiments described below, the plurality of pulses have a frequency in the range of 25 to 150 PPS.
[0036]
Further, according to features in the preferred embodiments described below, the local change is an increase in blood flow through the blood vessel.
[0037]
Further, according to features in the preferred embodiments described below, the local change is a decrease in blood flow through the blood vessel.
[0038]
Further, according to features in the preferred embodiments described below, the voltage difference is a plurality of voltage differences.
[0039]
Further, according to the features in the preferred embodiments described below, the voltage difference is controlled by the control means to induce a directional repetitive contractile movement in muscle tissue associated with the blood vessel, and the localization of blood flow through the blood vessel is controlled. An increase is achieved.
[0040]
Further, in accordance with features of the preferred embodiments described below, the control means controls the waveform to obtain a signal having a predetermined direction, frequency and intensity that induces a repetitive contractile movement in the muscle tissue.
[0041]
Further, according to features in the preferred embodiments described below, the apparatus further includes (e) a meter for measuring blood flow operatively coupled to the control means.
[0042]
Further, according to features in preferred embodiments described below, the control means is designed to initiate a sequence of electrical stimulation based on input from the meter.
[0043]
Further, according to features in the preferred embodiments described below, the meter includes a pressure sensor that presents blood pressure data.
[0044]
Further, according to features in the preferred embodiments described below, the control means is designed to synchronize the sequence of electrical stimulation with a pulse of blood corresponding to a heart beat.
[0045]
Further, according to features in the preferred embodiments described below, the signal generator includes at least two signal generators.
[0046]
Further, according to features in the preferred embodiments described below, the apparatus further includes (e) an amplifier operatively connected in parallel to the signal generator.
[0047]
The present invention overcomes the shortcomings of existing technologies by providing a painless, external, non-invasive method of increasing or decreasing local blood flow. The present invention is simple, easy to adjust, and easily adaptable to the needs of a particular patient.
[0048]
The present invention will be described by way of examples with reference to the accompanying drawings. Reference will now be made in detail to the drawings, wherein the specific matters shown herein are presented by way of example only and for the purpose of illustrating a preferred embodiment of the invention, and illustrate the principles and conceptual aspects of the invention in the most useful form. And emphasize that it is presented in an easily understandable form. In this regard, no attempt has been made to detail the structural details of the invention beyond what is necessary for a basic understanding of the invention, but from the drawings and description, it will be apparent to one skilled in the art. It will be clear how to actually embody several aspects of the invention.
BEST MODE FOR CARRYING OUT THE INVENTION
[0049]
According to the present invention, there is provided a treatment method for locally enhancing blood flow through a blood vessel in a specific region of the body.
[0050]
The principle and operation of the method according to the invention can be clearly understood from the drawings and the description.
[0051]
Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention may be used in the following description or in the structural details shown in the drawings and combinations of components. It is not limited. The invention may be practiced or practiced in other embodiments or in various ways. It should also be understood that the terms and terms used herein are for description and should not be considered limiting.
[0052]
As used herein, in the specification and in the claims, the term "polarity" refers to the absolute amount of voltage, including zero voltage.
[0053]
The terms "modulated" and "modulation" as used herein, in the specification and in the claims, are in accordance with the known methods in the art and which can be achieved using a variety of commercially available devices. Refers to a process that changes one or more properties of
[0054]
The term "voltage difference" as used herein, in the specification and in the claims, refers to the absolute difference between two distinct voltage values.
[0055]
The term "peristalsis" as used herein, in the specification and in the claims, means that one or more tubes carrying a fluid are compressed in a series of coordinated contractions or constrictions to move the fluid in a desired direction. Mention common properties of peristalsis.
[0056]
As used herein, in the specification, and in the claims, the term "blood flow measured by a meter" or the like means a flow rate measured by a meter using a direct or indirect method. The term also refers to a direct or indirect instrumental method of sensing the heartbeat or pulse. In particular, the term is intended to include methods of determining relative or absolute blood flow velocity, or using a pressure sensor to sense a pulse.
[0057]
FIG. 1 is a schematic diagram showing a part 20 of a forearm. A first electrode 22 is provided at one end of the portion 20, and a second electrode 24 is provided at the opposite end. Electrodes 22 and 24 are operably connected to a power supply (not shown). As is known in the art, muscle tissue can be contracted by applying an appropriate voltage difference and current to electrodes 22 and 24 (see FIG. 2). The contraction occurs at a point 26, approximately centered between electrodes 22 and 24, after a certain delay.
[0058]
FIG. 2 is a schematic diagram showing an internal tissue of the forearm portion in FIG. 1, and includes a bone 151, a muscle fiber forming a muscle 153, and a fluid tube 152. A tube 152 (general term for a conduit that carries blood, including but not limited to arteries and veins) located between muscle 153 and skin 150 carries blood along substantially the entire length of muscle 153. .
[0059]
After applying current to the electrode groups 110 and 120, muscle contraction occurs, causing swelling in the fibers of the muscle 153, ie, an aneurysm 154, which strikes the tube 152 at the stenosis point 155.
[0060]
The inventor has discovered that this phenomenon can be used to increase blood flow through the tube 152. Without wishing to be limited by theory, the inventors attribute the peristaltic effect to an increase in blood flow along the entire length of the muscular tissue where such currents cause continual muscle contraction and vasoconstriction. A series of blood vessel stenosis occurs within a very short period of time, and the blood flow in the blood vessel increases in a predetermined direction by the electrical stimulation supplied to the electrodes.
[0061]
The operation of the peristaltic pump can be better understood with reference to FIG. A typical peristaltic pump uses a tube 130 that contains and carries the fluid to be transferred. The wall 135 of the tube 130 is typically formed from a resilient, flexible synthetic material, and the tube 130 conforms to a U-shaped pattern as shown. For this tube, three rollers 137, 139 and 141 are arranged radially equidistant on a frame 140, which is typically driven by an electric motor in the direction 136 shown. The axis of the frame 140 is positioned so that two of the three rollers compress and squeeze the tube 130, the roller 139 creates a stenosis point 144, and the roller 141 creates a stenosis point 143. Rotating the frame 140 in a counterclockwise direction produces a pumping action. Fluid portion 133 is aspirated inward in direction 131 and fluid portion 142 is transported between constrictions 143 and 144 created by rollers 141 and 139, respectively, and travels along direction 136 to produce fluid portion 134. Move outward in direction 132. Therefore, blood flows from the inlet 124 to the outlet 126 by peristalsis.
[0062]
Peristaltic transport by involuntary wavy stenosis in muscle tissue is an internal mechanism for moving food along the entire length of the digestive tract. The arterial muscular wall unconsciously expands or contracts to increase or decrease blood flow.
[0063]
According to the present invention, a series of external electrical stimuli is applied to cause muscle contraction (and consequent narrowing of adjacent blood vessels) along the entire length of the muscle tissue in a timely manner that contributes to the peristaltic flow. This principle can be applied by providing
[0064]
The peristaltic pump effect can be achieved by various methods. As an example, FIG. 4 is a schematic diagram of the forearm portion 20 shown in FIG. 1, but a series of electrodes 51 to 60 are attached between the portion A and the portion B of the forearm portion 20. It should be emphasized that FIG. 4 and the sequence of applying the number of electrodes, electrode locations, and voltage differences in the description are provided by way of example for the description of the invention and should be familiar with the technology. Obviously, many other arrangements and sequences are possible.
[0065]
The electrodes 51 to 60 are operatively connected to one or more signal generators (not shown), but in this example a single signal generator is used. First, the signal generator supplies the electrodes 51 and 52 with an appropriate voltage difference and current. After a certain delay, contraction of the muscle tissue occurs at an intermediate point 62 between the electrodes 51 and 52. As described above, this contraction causes narrowing of the blood vessels adjacent to the muscle tissue. Thereafter, the signal generator supplies a voltage difference to the electrodes 51 and 52, this time causing the muscle tissue to contract further at a point 64 approximately at the center between the electrodes 51 and 53. The signal generator then applies a voltage difference to the electrodes 51 and 54, causing a further contraction of the muscle tissue at a point 66, which is now halfway between the electrodes 51 and 54. The signal generator then applies a voltage difference to the electrodes 51 and 55, causing the muscle tissue to contract further at point 68, which is now halfway between the electrodes 51 and 55. Electrodes other than electrode 51 may be advantageously activated. Thus, in the next stage of the sequence, the signal generator may provide a voltage difference to the electrodes 52 and 55, and this time at the approximate center 70 between the electrodes 52 and 55, may further contract the muscle tissue. The above sequence may be continued until a final contraction (at point 72) is achieved by applying a voltage difference to electrodes 59 and 60.
[0066]
As described above, a series of muscle contractions is propagated between the region A and the region B of the forearm 20 along the entire length of the muscle tissue. This series of muscle contractions causes adjacent blood vessels to contract and the peristaltic pump to work effectively, thus increasing blood flow.
[0067]
In addition, the inventor can apply a peristaltic pump from site A to site B on the blood vessel between site A and site B previously shown in FIG. 4 without arranging electrodes across the entire length. It was discovered that. FIG. 5 is a schematic view of the forearm portion 20 shown in FIG. 1 and FIG. 4, in which a first electrode pair 80A and 80B and a second electrode pair 82A and 82B are attached. As an example, electrodes 80A and 82A are located near the end of site A of forearm portion 20, and electrodes 80B and 82B are located near the end of site B. As shown in FIG. 7a, each electrode pair is operatively connected to a different signal generator. First, the first signal generator 85 applies a voltage difference to the first pair of electrodes 80A and 80B. Immediately thereafter, the second signal generator 87 applies to the second pair of electrodes 82A and 82B a voltage difference whose sign is inverted with respect to the initial stimulus supplied to the first pair of electrodes 80A and 80B. I do.
[0068]
As a result, initial muscle contraction does not occur at the center between the aforementioned electrode pairs, as expected, but at point 86 near the end of site A. While not wishing to be limited by theory, this phenomenon is essentially different from the ideal resistance of a muscle in that it is a very complex resistance with an inherent delay in contraction. I think it is related to the fact that they are different. Anyway, after a short time, another voltage difference is applied by the first signal generator 85 to the first pair of electrodes 80A and 80B. Immediately thereafter, a voltage difference is applied by the second signal generator 87 to the second pair of electrodes 82A and 82B as described above. As a result, the muscle continues to contract from point 86 to point 88. This sequence is repeated several times, causing the contraction point to transition from point 88 to point 90, from point 90 to point 92, and ultimately reach the point 94 located near site B. As described above, the point of stenosis of an adjacent blood vessel (see FIG. 3) is substantially comparable to the point of contraction of muscle tissue. Thus, directional stenosis of the blood vessel increases the flow in the blood vessel due to the peristaltic effect. If the directional stenosis of the blood vessel is opposed to the direction of natural flow in the blood vessel, the peristaltic effect will reduce blood flow from the heart.
[0069]
As soon as point 94 is reached, the cycle is restarted and the contraction point is re-established near point 86.
[0070]
Preferably, a voltage difference is applied to the second pair of electrodes 82A and 82B by the second signal generator 87. In this case, the sign of the voltage difference is reversed with respect to the initial stimulus supplied to the first pair of electrodes 80A and 80B, and the first signal generator 85 applies the voltage difference to the first pair of electrodes 80A and 80B. The timing is set so that the supply of the voltage difference is started before the operation is completed. Exemplary voltage versus time curves described in Example 1 below are shown in FIGS. 8a and 8b.
[0071]
FIG. 6 shows a simpler configuration of the present invention, requiring only a single pair of electrodes. FIG. 6 shows, by way of example, the forearm portion 20 shown in FIGS. 1, 4 and 5 with a single electrode pair 180A and 180B mounted at approximately the same location as the single electrode pair 80A and 80B shown in FIG. FIG. The electrode pairs 180A and 180B connect to four amplifiers (a1 to a4) in a differential floating scheme, as shown in FIG. 7b and described in more detail below.
[0072]
This configuration allows the electrodes of electrode pairs 180A and 180B to change polarity from positive to negative and back in the opposite direction by a program that the controller commands signal generators 85 and 87. In essence, electrode 180A performs the functions of electrodes 80A and 82A (FIG. 5), and similarly, electrode 180B performs the functions of electrodes 80B and 82B.
[0073]
7a is a schematic electrical diagram of the system referred to in the description of FIG. 5, and FIG. 7b is a schematic electrical diagram of the system referred to in the description of FIG. As shown in FIG. 7a, system 300 includes electrodes 80A and 80B coupled to amplifiers a1 and a2, respectively. The amplifiers a1 and a2 are further connected to a signal generator 85 which is connected to a power supply (not shown). Similarly, electrodes 82A and 82B are coupled to amplifiers a3 and a4, respectively. The amplifiers a3 and a4 are further connected to a signal generator 87 which is connected to a power supply (not shown). When the electrodes 80a and 80b (or the electrodes 82A and 82B) are brought into electrical contact with the area of the patient's skin, current passes through the area to complete the electrical circuit.
[0074]
As shown in FIG. 7b, system 400 includes electrode 180A coupled to amplifiers a2 and a3, and electrode 180B coupled to amplifiers a1 and a4. Amplifiers a1 and a2 are coupled to signal generator 85 as shown above in FIG. 7a. Similarly, amplifiers a3 and a4 are coupled to signal generator 87 as shown in FIG. 7a. Amplifiers a1 to a4 are arranged in a differential floating configuration.
[0075]
When the electrodes 180a and 180b make electrical contact with the area of the patient's skin, current passes through that area to complete the electrical circuit.
[0076]
The frequency, number, intensity and duration of muscle contractions are controlled by the modulation characteristics of the current passing through the electrodes. The treatment method of the present invention repeatedly provides a modulated voltage to the treatment area a sufficient number of times to provide a local increase in blood flow. This includes, but is not limited to, restoring muscle response from the effects of trauma, inactivity, reducing water retention in lower limbs, improving blood and lymph circulation and reducing pain, controlling erectile tissue function It is important for a wide variety of medical uses, including to provide treatment for and to accelerate healing, especially in diabetics. Restricting blood flow by inducing repetitive contractile movements of muscle tissue relative to natural blood flow is also applicable to a variety of medical applications, including various surgical procedures.
[0077]
Various frequencies and waveforms have been found to be effective in the method of the present invention. Suitable waveforms include square waves, transcendental function waves, spike waves, linear function waves, and step patterns. The frequency will vary considerably depending on the user's overall health, type of treatment, etc. and duration.
[0078]
Also, it should be emphasized that an experienced operator can adjust the waveform, frequency and intensity according to the needs of the individual patient.
[0079]
As shown in FIG. 7B, waveforms, frequencies, and the like generated by the signal generators 85 and 87 are controlled by the CPU 89. In the preferred embodiment of the present invention, the command parameters of CPU 89 are predetermined. It should be emphasized that various frequencies and waveforms have been found to be useful in connection with the method of the present invention. Suitable waveforms include square, transcendental, spike, linear, and step patterns. The frequency will vary considerably depending on the user's overall health, type of treatment and duration. Therefore, it is preferable that the apparatus be configured so that the operator can easily adjust such parameters of the CPU 89.
[0080]
Another preferred embodiment in which the CPU 89 controls the signal generator based on the input from the sensor 91 is shown below.
[0081]
FIG. 9a is a plot of blood flow through a blood vessel as a function of time before performing the treatment method of the present invention. The magnitude of the blood flow correlates with the linear velocity measured using a Doppler device. The large peak 220 corresponds to the linear velocity of blood through the blood vessels during each pulse (beat of the heart). The small peak 230 corresponds to the linear velocity of blood through the blood vessel during the pulse. The average amplitude of the large peak 220 is 21.1 cm / s. The average amplitude of the small peak 230 is 6.0 cm / s.
[0082]
After completion of the plot provided in FIG. 9a, the treatment method of the present invention was performed on the subject. FIG. 9b shows the linear velocity of blood flowing through a blood vessel as a function of time. The large peak 320 has an average amplitude of 30.8 cm / s and the small peak 330 has an average amplitude of 6.7 cm / s. Thus, the average amplitude of the large peaks has increased by 40-50%, indicating a significant increase in local blood flow through the blood vessels.
[0083]
FIG. 10a is another plot, similar to FIG. 9a, showing the linear velocity of blood flowing through a blood vessel as a function of time before performing the blood flow enhancement (BFE) method of the present invention. This linear velocity is measured using a Doppler device having an ultrasonic function for mapping a blood vessel.
[0084]
FIG. 10b is a plot showing the linear velocity of blood flowing through a blood vessel as a function of time, measured using the apparatus of FIG. 10a after application of the treatment method of the present invention.
[0085]
FIG. 11a is an enlarged view of the blood vessel mapping shown in FIG. 10a. This diagram is temporary because the diameter of the blood vessels changes over time and depends on the volumetric flow of blood, which is quite periodic to the heartbeat. FIG. 11b is an enlarged view of the blood vessel mapping shown in FIG. 10b, applying the inventive BFE method of the present invention. Based on the ultrasound data, it can be seen that the width of the blood vessels has increased compared to the width of the blood vessels in FIG. 11a. Volumetric flow through a blood vessel is proportional to the product of the cross-sectional area of the blood vessel and the linear velocity. Therefore, the percent increase in volumetric flow rate is calculated by multiplying the percent increase in linear velocity specified in FIGS. 9a and 9b by the square of the width ratio. It can be seen that the actual increase in blood flow through the blood vessels is even higher than the appreciable increase in blood velocity using the BFE devices and methods of the present invention.
[0086]
According to the present invention, there is provided a treatment method comprising the following steps for promoting a local increase or decrease in blood flow through a blood vessel in a body region. (A) (i) at least a first electrode operatively in contact with a first portion of body tissue, (ii) at least a second electrode in operative contact with a second portion of body tissue, and (iii) A) providing a system comprising a signal generator for providing a plurality of electrical stimuli having at least one voltage difference to the first electrode and the second electrode; And (b) providing a local increase or decrease in blood flow through the blood vessel by inducing a directional, repetitive contractile movement of muscle tissue associated with the blood vessel. In this case, provocation is achieved by exposing the muscle tissue to a voltage difference via the electrodes.
[0087]
Further, according to features in the preferred embodiments, the method further includes optimizing a local increase or decrease in blood flow. This optimization is preferably performed based on sensor control adjustments and / or blood flow from meter measurements.
[0088]
Those skilled in the art will be able to use a variety of means for measuring the timing of blood flow or the heartbeat with a meter, as described above, but pressure sensors are particularly suitable for this function. I know that In particular, miniature off-the-shelf pressure sensors, such as the Motorola Chip Pak High Volume Sensor for Low Pressure Applications (Serial No. MPXC2011DT1) for low pressure, allow easy connection to the CPU of the BFE device of the present invention. It is. Based on the data obtained from such sensors, the CPU controls the electrical signals to be generated.
[0089]
This is easy to understand in connection with FIG. 7b above. By way of example, sensor 91, which is a pressure sensor, is operatively connected to CPU 89 in system 400. The sensor 91 is external and located on the subject's skin and is used near the rest of the system 400. Sensor 91 is positioned to provide a continuous or semi-continuous reading of blood pressure near electrode 180a, arbitrarily defined as the electrode near the heart.
[0090]
The pressure in the blood vessels is characteristically pulsed and fairly periodic, corresponding to the heartbeat and blood circulation. Consequently, the maximum flow of blood through a blood vessel or group of blood vessels is sensed by the sensor 91. When the induction of a series of muscle contractions is synchronized with the maximum flow of blood supplied from the heart, the effectiveness of the blood flow enhancement of the present invention is significantly improved. Thus, after receiving the maximum reading, a reading close to the maximum reading, or a reading that exceeds a predetermined value, the CPU 89 receives a new reading (via the signal generators 85 and 87, the amplifiers a1 to a4, and the electrodes 180a and 180b). Preferably, it is configured to initiate a series of muscle contractions.
[0091]
Reference is now made to the following examples, which together with the above description, illustrate, without limitation, the invention.
Embodiment 1
[0092]
FIG. 8 shows an exemplary voltage versus time graph of the treatment method of the present invention using the systems depicted in FIGS. 7b and 6. The stimulus is a square wave with an intensity of 30 volts, each square wave having a duration of about 100 microseconds. It should be pointed out that the scale of the time axis is changed so that three complete periods are included in the graph.
[0093]
The initial stimulus provided to the electrode pairs 180A and 180B by the first signal generator 85 has a positive voltage difference (+30 volts). The second stimulus applied to the electrode pairs 180A and 180B by the second signal generator 87 has an opposite charge, ie, a negative charge of -30 volts. The second stimulus overlaps the first stimulus by about 50 such that the second stimulus ends approximately 50 microseconds after the end of the first stimulus.
[0094]
The time interval between positive stimuli (or between negative stimuli) is about 1 ms. Although only six stimuli are shown in FIG. 8, it is clear that practical therapy requires the majority of such stimuli.
[0095]
FIG. 8b is an oscilloscope trace showing another exemplary voltage versus time curve for a treatment method according to the present invention. Each pulse (or spike) has a voltage of up to 35V and a duration of 250 microseconds. This sequence is characterized by two positive spikes followed by two negative spikes. The load is about 500 ohms.
[0096]
Although the present invention has been described in relation to particular embodiments, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, all such alternatives, modifications and variations are intended to be included within the broad scope of the appended claims.
[Brief description of the drawings]
[0097]
FIG. 1 is a schematic diagram showing a part of a forearm with a first electrode and a second electrode.
FIG. 2 is a schematic diagram of an internal tissue of a forearm shown in FIG.
FIG. 3 is a partial sectional view illustrating the principle of a peristaltic pump.
FIG. 4 is a schematic diagram illustrating a method for increasing blood flow using multiple electrodes according to one aspect of the present invention.
FIG. 5 is a schematic diagram illustrating a method for enhancing blood flow using two pairs of electrodes operating in connection with a system having at least two signal generators.
FIG. 6 is a schematic diagram illustrating a method for enhancing blood flow using a single electrode pair.
7a is a schematic diagram representing a system for increasing blood flow according to the method of FIG.
FIG. 7b is a schematic diagram representing a system for increasing blood flow according to the method of FIG.
FIG. 8a is a graph showing an exemplary voltage versus time curve for a treatment method according to the present invention.
FIG. 8b is a graph showing another exemplary voltage versus time curve for a treatment method according to the present invention.
FIG. 9a is a plot of blood flow through a blood vessel as a function of time, measured using a Doppler device, during a normal cycle prior to initiating the treatment method of the present invention.
FIG. 9b is a plot showing blood flow through a blood vessel as a function of time when using the treatment method of the present invention.
FIG. 10a is a plot showing blood flow through a blood vessel as a function of time before administering the treatment method of the present invention. Blood flow was measured using a Doppler device with an ultrasound function that maps blood vessels.
FIG. 10b is a plot of blood flow through a blood vessel as a function of time using the apparatus of FIG. 10a when applying the treatment method of the present invention.
FIG. 11a is an enlarged view of the blood vessel mapping shown in FIG. 10a.
FIG. 11b is an enlarged view of the blood vessel mapping shown in FIG. 10b.

Claims (51)

A method of treatment that promotes a local increase in blood flow through blood vessels in an area of the body,
(A)
(I) at least a first electrode operatively in contact with a first portion of body tissue;
(Ii) at least a second electrode operatively contacting a second portion of body tissue; and (iii) a plurality of electrical contacts operatively connected to the first electrode and the second electrode. Providing a system including a signal generator for providing a stimulus; and (b) directional repetition of the muscular tissue associated with the blood vessel by applying the electrical stimulus to expose the muscular tissue to at least one voltage difference Inducing a contractile movement to produce a local increase in blood flow through said blood vessel. The method of claim 1, wherein the voltage difference is applied to the muscle tissue such that a periodic repetitive wavy motion occurs to impose a periodic repetitive peristaltic motion on the blood vessel. The at least first electrode is a first plurality of electrodes, the at least second electrode is a second plurality of electrodes, and the providing of a local increase in blood flow is the first plurality of electrodes. A plurality of, and the second plurality of, electrodes spaced along the entire length of the region; and a continuous between the first plurality of electrodes and the second plurality of electrodes. The method of claim 1, wherein the method is achieved by setting the at least one voltage difference in a simple and repetitive manner. further,
(C) arranging the at least first electrode at one end of the region and arranging the at least second electrode at a second end of the region, wherein the voltage difference set between the electrodes is 2. The method of claim 1, wherein the signal comprises two waveforms propagating in opposite directions to obtain a signal having a predetermined direction, frequency and intensity at which the repetitive contractile movement of muscle tissue is induced. The method of claim 4, wherein the at least first electrode is a first single electrode and the at least second electrode is a second single electrode. further,
The method of claim 1, comprising (c) optimizing the local increase in blood flow. The method of claim 6, wherein the optimization is based on adjusting a sensor control. 7. The method of claim 6, wherein the optimization is performed based on blood flow measured by a meter. 7. The method of claim 6, wherein a pressure sensor is used to measure the blood flow. further,
2. The method of claim 1, comprising: (c) synchronizing the plurality of electrical stimuli to a pulse of blood corresponding to a heart beat to obtain the local increase in blood flow. The method of claim 10, wherein the synchronization is achieved by monitoring blood pressure in the body. further,
The method of claim 1, comprising: (c) obtaining a periodic measurement of blood flow through the blood vessel; and (d) optimizing the local increase in blood flow based on the measurement. The described method. further,
2. The method of claim 1, comprising (c) modulating parameters of a wave signal set across the at least first electrode and the at least second electrode. 14. The method of claim 13, wherein the parameter comprises a frequency of the wavy signal. 14. The method of claim 13, wherein the parameters include a shape of the wavy signal. 14. The method of claim 13, wherein the parameter comprises a voltage of the wavy signal. further,
The method of claim 1, further comprising: (c) adjusting parameters of the repetitive contraction movement to achieve a predetermined target characteristic for the blood flow. 5. The method of claim 4, wherein the signal comprises a positive voltage difference phase and a negative voltage difference phase, wherein the positive phase and the negative phase have a time overlap. 19. The method of claim 18, wherein the time overlap is between 1 microsecond and 500 microseconds. 19. The method of claim 18, wherein the time overlap is between 10 microseconds and 100 microseconds. The method of claim 4, wherein the signal comprises a plurality of positive voltage difference peaks and a plurality of negative voltage difference peaks, each of the peaks having a duration of 30 to 500 microseconds. 22. The method of claim 21, wherein each of said peaks has a duration of 50 to 300 microseconds. 22. The method of claim 21, wherein each of the positive peaks has a duration of 150 to 300 microseconds. The signal comprises a plurality of pulses, each of the pulses including a positive voltage difference phase and a negative voltage difference phase, wherein the plurality of pulses have a frequency in the range of 0.5 to 150 pulses per second (PPS). 5. The method of claim 4, wherein A method of treating blood flow through a blood vessel in a region of the body to promote local changes,
(A)
(I) at least a first electrode operatively in contact with a first portion of body tissue;
(Ii) at least a second electrode operatively in contact with a second portion of body tissue; and (iii) a plurality of electrodes to the electrode operatively connected to the first electrode and the second electrode. Providing a system including a signal generator for providing electrical stimulation;
(B) disposing the at least first electrode at one end of the region and disposing the at least second electrode at a second end of the region; and (c) applying the electrical stimulus to the electrode. Setting a voltage difference between said electrodes, said voltage difference comprising two waveforms propagating in opposite directions between said electrodes, causing a local change in blood flow through said blood vessel . 26. The method of claim 25, wherein the electrical stimulation is applied to elicit a repetitive directional contractile movement in muscle tissue associated with the blood vessel. 26. The method of claim 25, wherein the local change is an increase in blood flow through the blood vessel. 26. The method of claim 25, wherein the local change is a decrease in blood flow through the blood vessel. further,
28. The method of claim 27, comprising (d) synchronizing the plurality of electrical stimuli with a pulse of blood corresponding to a heart beat to obtain the local increase in blood flow. A method of treating blood flow through a blood vessel in a region of the body to promote local reduction,
(A)
(I) at least a first electrode operatively in contact with a first portion of body tissue;
(Ii) at least a second electrode operatively in contact with a second portion of body tissue; and (iii) a plurality of the electrodes operatively connected to the first electrode and the second electrode. Providing a system including a signal generator for providing electrical stimulation; and (b) repeatedly contracting muscle tissue associated with the blood vessel by applying the electrical stimulation and exposing the muscle tissue to at least one voltage difference. A method of treatment comprising inducing exercise to generate a local decrease in blood flow through said blood vessel. 31. The method of claim 30, wherein the repetitive contraction movement is a directional movement. 31. The method of claim 30, wherein the voltage difference is applied to the muscle tissue to generate a periodic repetitive wavy motion that imposes a periodic peristaltic repetitive motion on the blood vessel. further,
(C) arranging the at least first electrode at one end of the region and arranging the at least second electrode at a second end of the region, wherein the voltage difference set between the electrodes is 31. The method of claim 30, wherein the signal comprises two waveforms propagating in opposite directions to obtain a signal having a predetermined direction, frequency and intensity at which the repetitive contractile movement of muscle tissue is induced. 34. The method of claim 33, wherein the signal comprises a positive voltage difference phase and a negative voltage difference phase, wherein the positive phase and the negative phase overlap in time. 35. The method of claim 34, wherein the time overlap is between 1 microsecond and 500 microseconds. 34. The method of claim 33, wherein the signal comprises a plurality of positive voltage difference peaks and a plurality of negative voltage difference peaks, each of the peaks having a duration of 30 to 500 microseconds. The signal comprises a plurality of pulses, each pulse including a positive voltage difference phase and a negative voltage difference phase, wherein the plurality of pulses have a frequency in the range of 0.5 to 150 pulses per second (PPS); 34. The method according to claim 33. A device for promoting local changes in blood flow through a blood vessel,
(A) at least a first electrode in operative contact with a first portion of body tissue;
(B) at least a second electrode operatively contacting a second portion of the body tissue;
(C) a signal generator operatively connected to the first and second electrodes for providing a plurality of electrical stimuli to the electrodes; and (d) controlling a signal generated by the signal generator. Control means,
The control means and the signal generator are designed and configured to set a voltage difference between the electrodes between the electrodes, the voltage difference being composed of waveforms propagating in opposite directions, and moving the electrodes, The device, wherein the difference facilitates a local change in blood flow through the blood vessel. 39. The device of claim 38, wherein the change is an increase in blood flow through the blood vessel. 39. The device of claim 38, wherein the change is a decrease in blood flow through the blood vessel. 39. The apparatus of claim 38, wherein said voltage difference is a plurality of voltage differences. The control means achieves a local increase in blood flow through the blood vessel by controlling the voltage difference to induce a directional repetitive contraction movement in muscle tissue associated with the blood vessel. Item 39. The apparatus according to Item 38. 39. The apparatus of claim 38, wherein the control means induces repetitive contractile movements in muscle tissue by controlling the waveform to obtain a signal having a predetermined direction, frequency and intensity. further,
39. The apparatus of claim 38, comprising (e) a meter for measuring blood flow operatively coupled to said control means. 45. The apparatus of claim 44, wherein the control means is further designed to initiate the sequence of electrical stimulation based on input from the meter. The apparatus of claim 44, wherein the meter comprises a pressure sensor and the input comprises blood pressure data. 39. The device of claim 38, wherein the control means is further designed to synchronize the sequence of electrical stimulation with a pulse of blood corresponding to a heart beat. 39. The apparatus of claim 38, wherein said signal generator comprises at least two signal generators. further,
39. The apparatus of claim 38, comprising (e) an amplifier operatively connected to said signal generator. The signal comprises a plurality of pulses, each of the pulses including a positive voltage difference phase and a negative voltage difference phase, wherein the plurality of pulses have a frequency in the range of 0.5 to 150 pulses per second (PPS). 39. The device of claim 38, having: 51. The apparatus of claim 50, wherein the plurality of pulses have a frequency in a range of 25 to 150 pulses per second (PPS).

Images